PrEP in Ireland Update: High Court clears the way for generic Truvada in Ireland

On Tuesday, November 7, the High Court in Dublin rejected an application from Gilead Sciences for injunctions that would have prevented two companies from marketing generic versions of Truvada in Ireland. With initial prices for these generics expected to be about 60% lower than what Gilead charges for brand-name Truvada, the timeline for PrEP access in Ireland could be shortened dramatically.

PrEP still won’t be available through the HSE, people wanting to use PrEP now will still be sourcing it online, and Irish Customs will still seize any shipments of generic PrEP that it intercepts.

Although generic manufacturers Teva and Mylan appear to be ready to enter the Irish market, generic versions of Truvada won’t be in pharmacies here next week. And when the generic versions do become available they’ll likely cost around €180 per month. That won’t be much use for individual users, but it makes a big difference for the HSE’s cost-effectiveness calculations.

So what’s happens next? First a generic manufacturer must submit an application for reimbursement for their product as PrEP to the HSE. This will go through a “rapid review” process that will assess whether or not it’s cost effective at the price offered. If not, it will start a more in-depth and lengthy review process.

Gilead Sciences submitted an application in June, but it failed to pass the initial “rapid review” process. Although Gilead is now involved in the drawn-out pharmacoeconomic assessment process (much of which involves haggling over price), an application from a generic manufacturer could make that process irrelevant.

Even after the HSE agrees to reimburse for PrEP, there are significant challenges to be addressed in actually providing PrEP. Although rates of STI and HIV testing in Ireland are low to begin with, the rates of diagnoses are increasing and the existing sexual health services in Ireland are already badly overstretched. Without a commitment to provide funding to properly support and expand the capacity of these services, access to PrEP may be severely limited.

Although we welcome this ruling and hope that it will hasten PrEP access in Ireland, it’s imperative that we keep pressure on the HSE and the Government. We need a real commitment from the highest levels of the HSE and the Government to make PrEP available without further delay.

The Irish response to the HIV crisis has been shamefully inadequate. We have an opportunity to change that, but it’s not going to happen unless we demand it.